BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1912020 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06428
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 11, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF FUNGAL PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THIS WAS ONE OF MULTIPLE REPORTS FROM THE SAME REPORTER AND SAME COMPLAINT. ON (B)(6) 2010, THE PATIENT DEVELOPED FUNGAL PERITONITIS, REQUIRING HOSPITALIZATION THE SAME DAY. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT BEGAN A 21 DAY TREATMENT WITH TRIFLUCAN, 100MG/DAY, INTRAVENOUSLY AND HAD HEMODIALYSIS. ACTION TAKEN WITH PD THERAPY AND WHETHER HEMODIALYSIS REMAINED ONGOING WAS NOT REPORTED. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE EVENT OF FUNGAL PERITONITIS RESOLVED THE SAME DAY. THE REPORTER CONSIDERED THE EVENT OF FUNGAL PERITONITIS MEDICALLY SIGNIFICANT AND THE UNSPECIFIED PD SOLUTION WAS CONSIDERED CO SUSPECT IN THIS REPORT. THE REPORTER CONSIDERED THE EVENT OF FUNGAL PERITONITIS RELATED TO EXTRANEAL AND THE UNSPECIFIED PD SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R EXTRANEAL VIAFLEX, UNSPECIFIED PD SOLUTION